R&D
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Job Title: Global Safety Officer

Location: Morristown, NJ , Cambridge, MA

About the Job

Are you ready to shape the future of medicine? The race is on to speed up drug discovery and development to find answers for patients and their families. Your skills could be critical in helping our teams accelerate progress.

We are an innovative global healthcare company with one purpose: to chase the miracles of science to improve people’s lives. We’re also a company where you can flourish and grow your career, with countless opportunities to explore, make connections with people, and stretch the limits of what you thought was possible. Ready to get started?

Main Responsibilities:

Internal & External Safety Expert with a clear and contemporary understand of Benefit Risk:

• Provide PV and risk management expertise to internal and external customers

• Safety expert for product must have an attitude of continuous learning and understand the product attributes and science

• Maintain knowledge of product, product environment, and recent literature

• Maintain expertise in drug safety and PV, and understanding of international safety regulations and guidelines

• Lead cross functional Safety Management Teams (SMTs) and GPV internal Safety Analysis Teams (SATs)

• Communicate with and represent PV position within project/product teams, with external partners, key opinion leaders, and Health Authorities, and during internal and external negotiations

• Provide strategic and proactive safety input into development plans

• Support due diligence activities and pharmacovigilance agreements

Impact:

• Ongoing assessment of the safety status of the product

• Review, preparation, contribution and/or approval of clinical development documents including clinical development plans, SAPs, study protocols, investigator brochures, data monitoring plans, study reports, integrated summary of safety, summary of clinical safety, and labeling

• Review, preparation, and/or contribution to questions/requests from health authorities, ethics committees/ IRBs, external partners

• Management of product safety alerts

• Ensuring the GPV’s position is well articulated to and understood by its internal and external stakeholders

• Continued visibility and Establishment of the credibility of GSO role/function and consequently GPV

• Signal Detection and Assessment:

• Responsible for overseeing from multiple contributors signal detection and analysis

• Collaborate with Center of Excellence for Signal Detection and Data Mining and the Safety Epidemiology group

• Identify and implement proactive safety analysis strategies to further define the safety as well as Benefit Risk profile.

• Lead the review of aggregate safety data and related activities as well as coordinate safety surveillance activities

About You

Qualifications:

Knowledge and Skills

• Excellent clinical judgment

• Articulate and clearly understood in telephone communications

• Capability to synthesize and critically analyze data from multiple sources supported by sound clinical reasoning

• Ability to communicate complex clinical issues and analysis orally and in writing

• Able to develop and document sound risk assessment

• Demonstrates initiative and capacity to work under pressure and with a good sense of Prioritization of business critical deliverables

• Demonstrates leadership within cross-functional team environment

• Excellent teamwork and interpersonal skills are required

• Fluency in English (written and spoken).

Formal Education And Experience Required

• M.D. Degree or equivalent. (i.e. MB.BS or DO)

• MD, Board Certified/Board eligible, or international equivalent, is preferred

• M.D., minimum 2-3 years' of unsupervised clinical practice (not residency) and a minimum of 3 years in total experience in international or large market pharmacovigilance, or at least 4 years of clinical development experience

• Exceptionally, candidates may be considered if they have proven excellence in a similar prior position, even if they have less than 3 years international PV experience.

Why Choose Us?

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.​

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.

Strebe nach Fortschritt. Entdecke Einzigartiges.

Werde Teil von Sanofi und starte mit uns in eine neue Ära der Wissenschaft – wo dein persönliches Wachstum genauso wegweisend ist wie unsere Arbeit. Wir investieren in dich, damit du weiterkommst, schneller denkst und Dinge möglich machst, die vorher undenkbar waren. Du wirst Grenzen verschieben, Gewohntes hinterfragen und smarte Lösungen entwickeln, die direkt bei den Menschen ankommen, für die wir da sind. Bereit, die Wunder der Wissenschaft zu jagen und Leben zu verbessern? Dann lass uns gemeinsam Großes bewegen – und das Außergewöhnliche entdecken.

Bei Sanofi stehen allen die gleichen Chancen offen – unabhängig von Herkunft, Hautfarbe, Religion, Geschlecht, Nationalität, sexueller Orientierung, Alter, Staatsangehörigkeit, Familienstand, Behinderung, Geschlechtsidentität, Veteranenstatus oder anderen gesetzlich geschützten Merkmalen.